The present invention generally relates to systems and methods for reducing the incidence of post-surgical complications. In particular, the present invention relates to tissue treatment systems and methods thereof for reducing post-surgical tissue adhesions at incision sites and/or at other sites distal thereto by treating the tissues prior to the incision thereof.
As a result of the healing process that follows abdominal, pelvic, cardiothoracic, or orthopedic surgery, complications frequently arise due to the natural tendency of the body to form adhesions, which are typically connective tissue structures that form between injured areas within body cavities. Adhesions may form regardless of the nature of surgical procedures, whether done in a so-called minimally invasive fashion using laparoscopy or with a standard technique involving one or more relatively large incisions. These tissue bridges may cause various, often serious, complications. Relieving the post-surgical complications caused by adhesions generally requires another surgery. However, the subsequent surgery is further complicated by adhesions formed as a result of the previous surgery. In addition, the second surgery is likely to result in further adhesions and a continuing cycle of additional surgical complications.
One example of a problem that can be caused by adhesions is that following abdominal surgery loops of intestine may become entangled or twisted about these adhesions. The entanglements cause partial or total flow obstruction through the bowel or may compromise the blood flow to and from the bowel. If such a condition is not relieved rapidly, the bowel dies and shortly thereafter the condition may cause death of the afflicted patient. Another problem due to adhesions is infertility in women. Adhesions that form after gynecological surgery, especially tubal surgeries and myomectomies, are a common cause of infertility. Adhesions can form between the ovaries, fallopian tubes or pelvic walls. These adhesions can block the passage of ovum from the ovaries into and through the fallopian tube. Adhesions around the fallopian tubes can also interfere with sperm transport to the ovum, thus resulting in infertility. Another common problem after abdominal or pelvic surgery in women is pelvic pain due to post-surgical adhesions.
Various suggestions have been made to avoid, reduce, and/or eliminate the formation of adhesions. For instance, standard surgical procedures in the United States often include the steps of using powder-free gloves, washing powder from gloves prior to surgery, and washing body cavities thoroughly prior to closing incisions. Another of the strategies that has been suggested to prevent adhesion formation is to loosely place a non-reactive barrier between an injured peritoneal surface and internal organs. Materials such as Interceed(trademark) and Seprafilm(trademark) and methods as described in U.S. Pat. No. 5,791,352 to Reich et al. have been advocated for minimizing adhesions. Also pourable substances (solidifying liquid gel material) have been used to prevent adhesion formation. These measures, unfortunately, have had only modest success in reducing the formation of post-surgical adhesions at the surgical locations.
Therefore, there exist needs for new tissue treatment systems and methods thereof that would eliminate or minimize post-surgical adhesions.
The present invention generally relates to systems and methods for reducing the incidence of post-surgical complications. In particular, the present invention relates to tissue treatment systems and methods thereof for reducing post-surgical tissue adhesions at incision sites and/or at other sites by treating the tissues prior or substantially prior to the incision thereof.
In one aspect of the present invention, a method to reduce post-surgical adhesions includes steps of applying energy at a surgical incision site in a controlled manner, measuring or monitoring a parameter indicative of an amount of energy applied at the incision site, and applying the energy until the measured parameter corresponds to a value that indicates the energy application will result in a reduction in post-surgical adhesions. The energy may be applied on one or two surfaces of the tissue at the incision site. In a preferred embodiment the tissue is then cut after the adhesion reduction treatment, along the areas of tissue treated. The parameter measured may include tissue impedance, duration of energy application, tissue temperature, rate of change of tissue temperature, tissue appearance, or a combination of any of these parameters.
In a further embodiment of the invention a system for treating tissue to reduce post-surgical adhesions includes a first member configured to be placed on one surface of the tissue to be treated and a second member configured to be placed on an opposite side of the tissue to be treated, to back up the first member. A treatment element is disposed on at least one of the first and second members. The treatment element is configured to deliver energy to the tissue. Actuating means is provided to move the first and second members from an open to a closed position wherein the members and thus the treatment element are brought into apposition to the tissue. A control means, which may include a processor, is configured to preferably provide precisely controlled treatment parameter(s) through the treatment element in a manner which reduces post-surgical complications when the tissue thus treated is cut.
Alternatively, a system may also have one tissue contacting member on which at least one treatment element is disposed. In a situation where only one side of the tissue can be contacted, e.g., the anterior abdominal wall during laproscopic surgery, the tissue contacting member can provide the desired treatment through the treatment element(s).
According to a further preferred embodiment, the first or second member is provided with at least one sensor which measures at least one parameter, which may include the temperature of the tissue, amount of energy generated by the treatment element, amount of energy delivered to the tissue, the impedance of the tissue, or the appearance of the tissue.
Other features and advantages of the invention will be apparent from the following detailed description and from the appended claims.